FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 3881625
·
Received April 8, 2014
Report
- Report Number
- 8010042-2014-00134
- Event Type
- Malfunction
- Date Received
- April 8, 2014
- Date of Event
- March 1, 2014
- Report Date
- March 11, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INFORMATION OF WHAT PROMPTED THE REPAIR HAS NOT BEEN RECEIVED. HOWEVER, THE LOGS THAT WERE RECEIVED CONTAIN SEVERAL ALARMS THAT INCLUDE ERROR CODES INDICATING DC POWER ERROR CODES. FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
IN A CALL TO OUR TECHNICAL SUPPORT, IT WAS REPORTED THAT THE HOSPITAL BIOMED STATED THAT REPAIR WORK ON A VENTILATOR HAS BEEN ONGOING FOR SOME TIME. THE BIOMED EXPLAINED THAT DURING TROUBLESHOOTING MANY PRINTED CIRCUIT BOARDS HAVE BEEN SWAPPED. FURTHERMORE, THE BIOMED STATED THAT THERE WERE MULTIPLE ISSUES AND MANY ERROR CODES. THE BIOMED DOWNLOADED THE LOGS AND SENT THEM. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212303 | SERVO-I | CBK | MAQUET CRITICAL CARE AB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |